Kornimate/medical-research-clean huggingface dataset:
safety of spd465 in treating adults with adhd.

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the purpose of this study is to assess the safety and effectiveness of spd465 in the treatment of adhd. the study will also look at how spd465 affects sleep.


Eligibility criteria:
inclusion criteria: * subject satisfied all entry criteria for the antecedent protocol (spd465-301 or spd465-303) and completed a minimum of 4 of the 7 weeks of double-blind treatment without experiencing any clinically significant adverse events. * subject must be male or non-pregnant female who agrees to comply with using acceptable contraceptive methods. exclusion criteria: * subject was terminated from antecedent protocol (spd465-301 or spd465-303) for non-compliance and/or experienced a serious adverse event or adverse event resulting in termination from the protocol. * comorbid psychiatric diagnosis with significant symptoms such as axis ii disorders or severe asix i disorders. * history of seizure, tic disorder, or a current diagnosis and/or family history of tourette's disorder. * females who are pregnant of lactating.
genetic studies in alzheimer's disease

Conditions: Alzheimer's Disease; Nervous System Disease

Summary: alzheimer's disease is a condition marked by the deterioration of mental function. the disease usually begins in late middle life and results in death in 5 to 10 years. patients with alzheimer's disease typically suffer from memory loss, confusion, and disorientation. the condition has become a major medical and social problem in the united states because of the increasing number of people living beyond the age of 65. the actual cause of alzheimer's disease is unknown. researchers believe that alzheimer's disease, or at least a portion of cases, may be an inherited condition. as a result, many new techniques have been developed to study the genetic causes of alzheimer's disease and other neurological disorders. many of these genetic techniques require blood samples and a family pedigree. a pedigree is a chart, similar to a family tree, that shows a patient's family history. the purpose of this study is to collect family and psychosocial information, blood, and biopsy samples from patients with neurological diseases, their families, and normal volunteers. this information gathered will be used to learn more about diseases that affect the brain.

this is a screening and follow-up protocol. recent technological advances have facilitated the development of new approaches for investigating the underlying genetic basis of neurological disorders, but genetic questions remain open and on going. application of many genetic techniques require a family pedigree and blood sample. peripheral blood lymphoblasts which are banked also serve as a renewable source for harvesting dna which can be used for developing genetic markers in the future. this study will allow collection of family and psychosocial information and blood specimens from patients with neurological diseases, their families, and normal control subjects.

Eligibility criteria:
inclusion/exclusion criteria need to know extensive family history information.

Keywords: primary neuronal degeneration genetics neurotransmitters dna lymphoblasts skin fibroblast alzheimer's disease
the effect of beetroot juice on plasma trimethylamine n-oxide concentration

Conditions: Hypertension

Summary: the primary aim of the current study is to determine the effect of beetroot juice consumption on plasma trimethylamine n-oxide concentration. a secondary aims: exploring the effect of circulating trimethylamine n-oxide modification on plasma total antioxidant status, and measurement of changes in the skin nicotinamide-adenine dinucleotide reduced form (nadh) content during transient ischemia and reperfusion.

in a random order subjects will consume beetroot juice (140ml), or equimolar nitrates (nano3). antecubital vein blood samples will be taken at the beginning, and every hour for 4 hours following consumption. plasma trimethylamine n-oxide, total antioxidant status, and nitrite/nitrate concentrations will be determined. using flow mediated skin fluorescence skin nadh content determined during controlled ischemia triggered by total occlusion of the brachial artery by the brachial blood pressure cuff and during reperfusion after deflation of the blood pressure cuff 2 and 4 hours following consumption.

Eligibility criteria:
inclusion criteria: healthy volunteers exclusion criteria:
focused ultrasound for the treatment of pancreatic cancer - an international registry

Conditions: Pancreatic Cancer

Summary: this pancreatic cancer registry aims to collect information on people around the world who select focused ultrasound (fus) as part of their treatment for pancreatic cancer to learn about the performance of the focused ultrasound technology and health outcomes; the impact of focused ultrasound on your overall health; and provide an understanding of the current care for pancreatic cancer.

the purpose of the registry is to collect data on the performance of the focused ultrasound (fus) technology and health outcomes. a wide variety of approaches exist for using fus on pancreatic cancer patients, and the primary goal is to capture this broad spectrum of approaches and their impact on patients overall health. this information will help provide a better understanding of current care, and may possibly direct further, more specific investigations that will follow this registry. after obtaining informed consent a baseline history, physical examination, laboratory studies, and imaging studies needed per standard of care will be performed. patients' treatment is determined by their caregivers only, and thus the registry will evaluate patient management in "real-world" conditions. enrollment goal: 100 primary outcomes: pain related to pancreatic cancer, objective response, progression-free and overall survival, performance status, clinical benefit response (cbr), health-related quality of life

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all registry procedures and availability for the duration of the registry * histology proven pancreatic carcinoma in any area of pancreas * pancreatic tumor that can be treated by fus * willingness and ability to complete follow-up interviews exclusion criteria: * any disease, condition or surgery which would result in a contraindication to undergoing fus therapy. * clinical trials of pancreatic cancer not of focused ultrasound or related activities * other non-pancreatic cancer clinical trials

Keywords: pancreatic cancer focused ultrasound
study to compare the tolerability and efficacy of once daily vardenafil vs vardenafil prn vs placebo in men immediately after nerve-sparing prostatectomy for improving ed

Conditions: Erectile Dysfunction; Sexual Dysfunction, Physiological

Summary: a study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.


Eligibility criteria:
inclusion criteria: at screening * males 18-64 years of age * scheduled to undergo bilateral nerve-sparing radical retropubic bnsrrp, as selected according to the investigator's usual clinical practice * surgery scheduled within about 1 month of screening (visit 1) * expressed an interest in resuming sexual activity as soon as possible after prostatectomy * heterosexual relationship * no pre-operative erectile dysfunction: * international index of erectile function (iief) erectile function domain score score ef domain =26 at screening without any therapy/devices for improvement of erections * no perforation of the prostate capsule by tumor at randomization: before being randomized subjects must still be meeting all screening inclusion criteria, as well as the following criteria: * bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report * bnsrrp occurred within approximately 1 month post screening (visit 1) * no perforation of the prostate capsule by tumor: no positive tumor margins confirmed after surgery: =t2 stage on pathology report from the surgery exclusion criteria: * subjects who are taking nitrates or nitric oxide donors * subjects who are taking the following inhibitors of cytochrome p 450 cyp 3a4: very potent hiv protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin * known hypersensitivity to vardenafil * presence of significant penile anatomical abnormalities (e.g. penile fibrosis or peyronie's disease) * history of retinitis pigmentosa * unstable angina pectoris * history of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months * severe chronic or acute liver disease * symptomatic postural hypotension in the past 6 months * nyha class iii or iv heart failure * life expectancy \<3 years * clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h) * anti-androgens use * residual prostate cancer, or requirement for radiotherapy or adt after surgery
efficacy, safety and tolerability of cg428 cutaneous solution on chemotherapy induced alopecia; controlled study (elan)

Conditions: Alopecia

Summary: phase ii clinical trial

the aim of this trial is to compare the degree of efficacy, safety and tolerability of cg 428 cutaneous solution versus placebo on prevention of chemotherapy induced alopecia (cia) in female patients with metastatic cancer treated with selected regimens inducing alopecia.

Eligibility criteria:
inclusion criteria: * adult female, age ≥ 18 years. * patient with cancer, requiring one of the following pre-specified chemotherapy regimen according to local guidelines: weekly paclitaxel, weekly docetaxel, eribuline or associationof weekly paclitaxel/docetaxel with carboplatine (association of targeted therapies not influencing significantly the risk of alopecia is allowed, i.e. trastuzumab, pertuzumab or bevacizumab). * healthy hair (no current alopecia or scalp disease treatment). * life expectancy ≥ 6 months. * able to use the study treatment in compliance with the protocol. * physical and psychological ability to participate. * negative serum pregnancy test within 14 days prior to randomization in premenopausal women with childbearing potential. * patients must agree to not shave their head (minimum ≥ 1 cm). * signed and dated informed consent. exclusion criteria: * other ongoing anti-neoplastic therapy or other investigational drug with potential effect on hair growth. * patients treated with proteasome inhibitors, i.e. bortezomib. * prior radiotherapy to the scalp with residual alopecia. * known allergy or hypersensitivity to some components of cg 428 cutaneous solution (including allium cepa (onion), citrus, caffeine, theobromine). * pre-existing alopecia or significant scalp disease, which may alter study treatment administration or absorption. * concomitant use of cold cap or any other anti-hair loss treatment. * hair transplants.

Keywords: alopecia hair chemotherapy cancer
efficacy, safety, tolerability, pharmacokinetics of sotrastaurin-tacrolimus vs. mycophenolic acid-tacrolimus in de novo liver transplant patients

Conditions: Liver Transplantation

Summary: this study will assess the safety and efficacy of different doses of sotrastaurin when combined with tacrolimus for the prevention of acute rejection after de novo liver transplantation.


Eligibility criteria:
inclusion criteria: * recipients of any race, 18 years or older * recipients of primary de novo orthotopic liver transplant from a deceased donor * recipients of a kidney with a cold ischemia time \< 30 hours * hcv-negative recipients exclusion criteria: * prior organ/cellular transplant or multiple organ transplant * meld-score \> 35 * hcc \> milan criteria * donor age \< 12 years * cold ischemia \> 15 hours * patients who are treated with drugs that are strong inducers or inhibitors of cytochrome p450 3a4 (cyp3a4) or drugs with qt-prolonging properties other protocol-defined inclusion/exclusion criteria may apply

Keywords: liver transplantation hcv-negative recipient deceased donor sotrastaurin oran transplantation tacrolimus
factors affecting post-treatment outcomes in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: easl and mrecist criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma who were treated with different modalities of therapy according to the bclc classification, and detect the possible predictors of post-treatment outcomes.

background: easl and mrecist criteria differ from each other in terms of the number of target lesions (all versus \< = 2) and calculation method (bidimensional versus unidimensional). therefore, the investigators aimed to retrospectively analyze and compare the clinical outcomes among patients with hepatocellular carcinoma (hcc) who were treated with different modalities of therapy according to the bclc classification, and detect the possible predictors of post-treatment outcomes. methods: this work was conducted at the departments of tropical medicine and gastroenterology, internal medicine, and general surgery. this study included patients that matched our eligibility criteria for a period of five years started from june 2015 to may 2020. the study purpose was to retrospectively analyze the clinical outcomes among patients with hcc who were treated with different modalities of therapy according to the bclc classification, and detect the possible predictors of post-treatment favorable outcomes. the data of the patients were extracted and retrospectively reviewed from the patients' records and the databases of both hospitals (suh and soi). during the period of recruitment, 407 patients diagnosed with hcc admitted to our departments and followed-up attending outpatient clinics, sohag university hospitals, over a 5 years period.

Eligibility criteria:
inclusion criteria: * adult patients * with hepatocellular carcinoma exclusion criteria: * severely-ill patients * with other system comorbidities, * presence of extrahepatic metastasis, * patients who dropped from the follow-up list after treatment.

Keywords: hepatocellular carcinoma hcc hepatoma primary liver tumours
assessing the dose-response of muscle protein synthesis to "super-whey" in older adults

Conditions: Sarcopenia

Summary: skeletal muscle accounts for approximately 45-55% of total body mass in healthy adults and plays a pivotal role in whole-body metabolic health, locomotion and physical independence. undesirable loss of skeletal muscle mass (atrophy) is, however, a common feature of many diseases and scenarios including ageing, bed rest/immobilisation, cancer and physical inactivity. despite the exact mechanisms causing muscle atrophy being not yet fully understood, "anabolic resistance" (reduced muscle building in response to protein feeding and exercise) is thought to be key, especially for age-related skeletal muscle losses (known as sarcopenia). as such, the search for optimal strategies (e.g., exercise and/ or nutritional interventions) to combat this anabolic blunting remains a hot-topic in scientific research. leucine, an essential and branched chain amino acid (eaa/bcaa), is thought to be the most potent aa for stimulating muscle protein synthesis (mps; the muscle building process). although, as a stand-alone supplement, leucine is unlikely to provoke a robust and prolonged state of mps, low doses of leucine-enriched mixed-eaas can elicit similar increases in mps as compared to a large dose of whey protein. as reduced appetite and increased satiety (feeling fuller) are common with advancing age, supplementation of a low-dose protein (i.e., leucine-enriched) that can adequately stimulate mps may contribute to muscle health maintenance in older adults and reduce satiation following a meal. this study aims to examine which of three doses of a novel leucine-enriched whey protein ("super-whey") best stimulates muscle building in older adults


Eligibility criteria:
inclusion criteria: * participant is in the desired age-ranges (young adults: 18-35 years; older adults: 65+ years). * participant is willing and able to give informed consent for participation in the study. * participant is physically able to perform resistance exercise exclusion criteria: * a bmi \ 35 kg/m2 * active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (bp \> 160/100), angina, heart failure (class iii/iv), arrhythmia, right to left cardiac shunt, recent cardiac event, copd, pulmonary hypertension or recent (6 mo) stroke * any metabolic disease * clotting dysfunction * a history of, or current neurological or musculoskeletal conditions (e.g. epilepsy) * lactose intolerance * having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
oral paracetamol versus oral ibuprofen in management of patent ductus arteriosus in preterm infants: a randomised controlled trial

Conditions: Patent Ductus Arteriosus

Summary: the purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.

to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants. eighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours. one of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.

Eligibility criteria:
inclusion criteria: * birth weight below 1250 gram * diagnosed patent ductus arteriosus by echocardiographic examination exclusion criteria: * accompanied other congenital cardiac anomalies * urine output of less than 1 ml/kg/h during the preceding 8 h, * serum creatinine level \>1.6 mg/dl, * platelet count \<60,000/mm3, * liver failure, * hyperbilirubinemia requiring exchange transfusion * severe intracranial bleeding (grade iii - iv) * intestinal abnormality and necrotising enterocolitis

Keywords: patent ductus arteriosus paracetamol ibuprofen preterm infant
acute effects of vigorous-intensity aerobic exercise on glymphatic flow in healthy adults

Conditions: Glymphatic System; Neurodegeneration

Summary: this study investigates changes in glymphatic flow in the brain acutely after vigorous-intensity steady-state aerobic exercise. twenty subjects (10 male and 10 female) perform 25 minute submaximal cycle ergometry exercise and the changes in the glymphatic flow and cerebral perfusion are evaluated using a variety of mri sequences (e.g. mreg).

the glymphatic system is a drainage system for the brain to help maintain fluid balance and extract waste metabolites. glymphatic system function (healthy glymphatic flow) may prevent accumulation of harmful substances and therefore slow down the onset of neurodegenerative diseases. the hypothesis is, that glymphatic flow could be increased through exercise and enhanced cerebral arterial pulsality, which might explain some of the brain health benefits of exercise proven in epidemiological studies. this study indirectly investigates the acute changes in the glymphatic flow acutely after aerobic exercise using mreg that measures pulse wave propagation as an indirect surrogate marker for glymphatic flow. twenty healthy subjects (n=20, 10 male, 10 female, age 18-45 years) will perform 25 minute 70%vo2max cycle ergometry exercise. the glymphatic flow and cerebral perfusion will be measured using magnetic resonance imaging sequences before and after exercise. the glymphatic flow is measured using 10 hz fmri technique called magnetic resonance encephalography (mreg). in addition, perfusion mri is used to evaluate changes in brain perfusion.

Eligibility criteria:
inclusion criteria: * age 18-45 * bmi 18-30 * resting blood pressure \< 140/90 mmhg exclusion criteria: * history of a cardiac event * insulin or medically treated diabetes * any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results * presence of ferromagnetic objects that would make mr imaging contraindicated * claustrophobia * abundant use of alcohol * use of narcotics * smoking of tobacco or consuming snuff tobacco * diagnosed depressive or bipolar disorder * abnormalities in resting ecg (revised by the study physician) * pregnancy

Keywords: glymphatic system cerebral perfusion aerobic exercise
extension study of ace-031 in subjects with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: to evaluate the long-term safety and tolerability of ace-031 administration in subjects with duchenne muscular dystrophy (dmd) who participated in study a031-03. \[note: this study was terminated based on preliminary safety data. pending further analysis of safety data and discussion with health authorities, a new ace-031 trial will be planned.\]


Eligibility criteria:
inclusion criteria: * completion of participation in study a031-03 and investigator approval * continuation of corticosteroid therapy at the same absolute dose and schedule as on study a031-03 exclusion criteria: * participation in any other therapeutic clinical trial * plans to have surgery during the course of the study
cohort study of chronic heart failure

Conditions: Analyze Etiology, Comorbidities, Clinical Characteristics

Summary: the purpose is to understand the clinical characteristics of chronic heart failure as soon as possible, analyze the etiology, comorbidities, clinical characteristics, and treatment of heart failure patients, observe the gap between real-world clinical practice and guideline recommendations, and provide reference for the improvement of heart failure prevention and treatment in china.

inclusion criteria: 1. accompanied by difficulty breathing, fatigue, or decreased activity tolerance; 2. signs of fluid retention (pulmonary congestion and peripheral edema); 3. echocardiography shows abnormalities in cardiac structure and/or function; 4. elevated levels of natriuretic peptide: b-type natriuretic peptide (bnp)\>35 ng/l and/or n-terminal b-type probnp (nt probnp)\>125 ng/l. 5. hf hospitalization recorded within the previous 12 months exclusion criteria: 1. concomitant severe liver function, renal failure, or other severe system dysfunction 2. poor compliance, inability to obtain information, or voluntary refusal to participate in this study.

Eligibility criteria:
inclusion criteria: 1. accompanied by difficulty breathing, fatigue, or decreased activity tolerance; 2. signs of fluid retention (pulmonary congestion and peripheral edema); 3. echocardiography shows abnormalities in cardiac structure and/or function; 4. elevated levels of natriuretic peptide: b-type natriuretic peptide (bnp)\>35 ng/l and/or n-terminal b-type probnp (nt probnp)\>125 ng/l. exclusion criteria: 1. concomitant severe liver function, renal failure, or other severe system dysfunction 2. poor compliance, inability to obtain information, or voluntary refusal to participate in this study.